The project includes the consolidation of a methodology to manage process risk in the Cardiovascular Foundation of Colombia, specifically Strategic Business Unit (SBU)
Bioengineering. During 6 months of placement in the institution, the UEN Bioengineering took the initiative to manage risk in order to comply with guidelines
proposed by the ISO 13485:2003, Medical Devices - Quality Management Systems, which were certified last August 29, 2011.
The results were based on ISO 31000:2009, Risk Management - Principles and Guidelines, with the lines proposed by the international standard methodology and was the instrument with which to manage risks UEN processes for Bioengineering.
During the first 3 months of practice in the FCV, we performed an in-depth interpretation of the law and research concepts and different management methods on the guidelines proposed by the standard (identification, analysis, evaluation, treatment and feedback,
risk process), after this process of research was conducted socialization of these concepts and guidelines on risk management with the leaders of the 5 processes that comprise the FCV UEN Bioengineering, that socialization served as input to the process leaders to
7 start risk management in their respective areas, this second step took place within 3 months of practice, where he also conducted socialization and pooled on the progress of management, these opportunities are able to identify areas for improvement in relation to methodology and the instrument is called communication and consultation phase, one of the principles and guidelines proposed by the ISO 31000 - Risk Management. Until
completing the full implementation of the instrument and its validation, as well as the results of management.